Examining the Impact of an Online, Non-restrictive Diet Among Persons With Multiple Sclerosis

NCT ID: NCT05712408

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-04-19

Brief Summary

The current study aims to test an online, non-restrictive diet among persons with multiple sclerosis (MS). Diet is the number one searched second-line therapy among persons with MS, however there are currently no established dietary approaches to improve health and wellbeing among persons with MS. Participants will complete the 8-week diet program using an online application. The primary research question is whether the diet program is acceptable and can improve general health indicators including cholesterol, glucose, body weight, body fat as well as MS symptoms (i.e., walking, cognition, fatigue, and quality of life).

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Diet Intervention

8 week non-restrictive diet program

Group Type: EXPERIMENTAL

800g Challenge

Intervention Type: BEHAVIORAL

The intervention will involve 8 weeks of an online diet program. Outcomes testing will occur at baseline and post-intervention (following 8 week diet program). During the first 4 weeks, participants will receive educaitonal material and log their daily points in an online application and attend a weekly check-in call with members of the research team. During weeks 5-8, participants will log their daily points in the online application.

Interventions

800g Challenge

The intervention will involve 8 weeks of an online diet program. Outcomes testing will occur at baseline and post-intervention (following 8 week diet program). During the first 4 weeks, participants will receive educaitonal material and log their daily points in an online application and attend a weekly check-in call with members of the research team. During weeks 5-8, participants will log their daily points in the online application.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• age 18-70 years
• a self-reported diagnosis of multiple sclerosis
• relapse free in past 30 days
• non-pregnant
• willing and able to visit University of North Texas on two testing occasions

Exclusion Criteria

• electronic medical implant, such as a heart pacemaker or an implantable cardioverter defibrillator (ICD)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Texas, Denton, TX

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie Silveira

Role: PRINCIPAL_INVESTIGATOR

University of North Texas Health Science Center

Locations

University of North Texas

Denton, Texas, United States

Countries

United States

Other Identifiers

IRB-21-629

Identifier Type: -

Identifier Source: org_study_id